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Clinical Benefit of Topoisomerase Downregulation

This study has been completed.
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance Identifier:
First received: November 3, 2005
Last updated: September 2, 2011
Last verified: September 2011

1.1 To determine the regulation of topoisomerase I and II following alternating prolonged exposure to topotecan and etoposide (VP-16)

1.2 To determine the time to progression and the objective response rate of this treatment in patients with incurable ovarian cancer.

Condition Intervention Phase
Ovarian Cancer
Drug: Topotecan and VP16
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Benefit of Topoisomerase Downregulation: A Phase I Pilot Study

Resource links provided by NLM:

Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • To determine the regulation of topoisomerase I and II following alternating prolonged exposure to topotecan and etoposide (VP-16) [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • To determine the time to progression and the objective response rate of this treatment in patients with incurable ovarian cancer [ Time Frame: 3 years ]

Enrollment: 15
Study Start Date: May 2004
Study Completion Date: March 2006
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Topotecan and VP16

    Course 1A: On day 1 treatment will start with a continuous infusion of TPT at 0.4 mg/m2/day for 21 days. A pump will be used to deliver the TPT. The bag in the pump will be replaced every week for sterility precautions.

    Course 1B: On day 28, if ANC is >1,500 and platelets > 100,000, VP-16 will be administered orally at 50 mg/day for 14 days.

Detailed Description:
The rationale to study the downregulation of topoisomerase enzyme in ovarian cancer in relationship to the cell cycle distribution of the cancer cells after a prolonged continuous exposure to topo I and II poisons is to better understand the relationship between cell cycle and topo poisoning, which may lead to better clinical trial designs.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients, 18 years of age or older, with incurable ovarian advanced cancer are eligible provided that they have measurable disease by CT-scan imaging, or evaluable disease by tumor markers, following the criteria described by Rustin et al. (14). (Response to a specific treatment has occurred if after two CA-125 samples there has been a 50% decrease, confirmed by a fourth sample (50% response), or a serial decrease over three samples of greater than 75% (75% response). The final sample has to be at least 28 days after the previous sample.)
  • Patients must have a life expectancy of at least 12 weeks.
  • Patients must have a Zubrod performance status of 0-2.
  • Patients must sign an informed consent.
  • Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence of a regular red blood cell transfusion requirement.
  • Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.

Exclusion Criteria:

  • Patients with symptomatic brain metastases are excluded from this study.
  • Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
  • Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
  • Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
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Please refer to this study by its identifier: NCT00250094

United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Principal Investigator: Claire F Verschraegen, MD University of New Mexico
  More Information

Responsible Party: New Mexico Cancer Care Alliance Identifier: NCT00250094     History of Changes
Other Study ID Numbers: 0603C
Study First Received: November 3, 2005
Last Updated: September 2, 2011

Keywords provided by New Mexico Cancer Care Alliance:
Phase I
Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on May 25, 2017